510(k) · Cleared
ClearedSedecal Mobile X-Ray Units with Digital Detector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sedecal., Sa. · IZL System, X-Ray, Mobile
Cleared on Nov 18, 2004 as substantially equivalent to K012663 (Sedecal USA, Inc., 2001) and 1 other predicate after a 17-day review. Its family tree reaches back 4 generations to 1998. 52 later devices descend from it.
- Decided
- Nov 18, 2004
- Review
- 17 days
- Class
- Class II
- Product code
- IZL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K981556 (1998). 7 ancestors in all. 52 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 3 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 2 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 1 generation backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- This deviceK043002 Sedecal Mobile X-Ray Units with Digital DetectorSedecal., Sa. · 2004
- Descendant · cites it directly · 50 of its ownK090322 Easy Moving Plus, SM-XXHF-YYSedecal., Sa. · 2009 · Recalled
- Descendant · 2 generations on · 25 of its ownK142492 GM60A-32S, GM60A-40SSamsung Electronics Co., Ltd. · 2014 · Recalled
- Descendant · 3 generations on · 24 of its ownK150097 GM60A-32S & GM60A-40SSamsung Electronics Co., Ltd. · 2015 · Recalled
- Descendant · 4 generations on · 23 of its ownK162278 Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd. · 2016
- Descendant · 5 generations on · 22 of its ownK171119 GM85Samsung Electronics Co., Ltd. · 2017 · Recalled
Showing 5 of 52 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 52 · See all- K090322Easy Moving Plus, SM-XXHF-YYSedecal., Sa. · 2009 · cites it directly50descendants
- K142492GM60A-32S, GM60A-40SSamsung Electronics Co., Ltd. · 2014 · 2 generations on25descendants
- K150097GM60A-32S & GM60A-40SSamsung Electronics Co., Ltd. · 2015 · 3 generations on24descendants
- K162278Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd. · 2016 · 4 generations on23descendants
- K171119GM85Samsung Electronics Co., Ltd. · 2017 · 5 generations on22descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −3 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −2 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −1 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| 0 (this device) | K043002 | Sedecal Mobile X-Ray Units with Digital Detector | Sedecal., Sa. | 2004 | — |
| +1 | K090322 | Easy Moving Plus, SM-XXHF-YY | Sedecal., Sa. | 2009 | 31 |
| +2 | K142492 | GM60A-32S, GM60A-40S | Samsung Electronics Co., Ltd. | 2014 | 1 |
| +3 | K150097 | GM60A-32S & GM60A-40S | Samsung Electronics Co., Ltd. | 2015 | 2 |
| +4 | K162278 | Digital Diagnostic Mobile X-ray System | Samsung Electronics Co., Ltd. | 2016 | — |
| +5 | K171119 | GM85 | Samsung Electronics Co., Ltd. | 2017 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 9 | 0 |
| 2019 | 5 | 0 |
| 2020 | 2 | 0 |
| 2021 | 5 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 6 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IZL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IZL device
- #1 K242015 TOPAZ Mobile X-ray System (Models : TOPAZ-32D…score 19.9 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K012663 | Easy Moving Mobile X-Ray Unit (Model SM-HF)Summary page 1…ct Codes Product Code 90 1ZL and MQB Common/Usual Name: General purpose mobile diagnostic X-ray Unit. 2. Equivalent legally marketed devices: Sedccal Mobile X-Ray Units K012663 and Canon CXDI-50G Digital Radiography, K031447. The MODIFIED device COMBINES these two units. 3. Indications for Use (intended… | 2001 |
| * | K031447 | Canon, Digital Radiography, Model Cxdi-50GSummary page 1…l Name: General purpose mobile diagnostic X-ray Unit. 2. Equivalent legally marketed devices: Sedccal Mobile X-Ray Units K012663 and Canon CXDI-50G Digital Radiography, K031447. The MODIFIED device COMBINES these two units. 3. Indications for Use (intended use) The Sedecal Mobile Radiographic Systems wit… | 2003 |
What descends from it? (52)
See all 522 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K090322 (Sedecal., Sa., 2009) has gone furthest, with 50 descendants of its own.
- 1 other device also cites its predicate K012663.
How does its category compare?
All IZL devicesIZL System, X-Ray, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IZL
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IZL
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IZL
47in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZL
27in 2025
MAUDE reports naming product code IZL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 30 | 7 | 16 |
| 2008 | 4 | 49 | 0 | 27 |
| 2009 | 3 | 125 | 0 | 35 |
| 2010 | 3 | 65 | 4 | 75 |
| 2011 | 6 | 66 | 6 | 118 |
| 2012 | 3 | 83 | 5 | 24 |
| 2013 | 0 | — | 10 | 17 |
| 2014 | 7 | 104 | 4 | 51 |
| 2015 | 4 | 88 | 4 | 30 |
| 2016 | 6 | 47 | 0 | 33 |
| 2017 | 7 | 45 | 0 | 35 |
| 2018 | 8 | 47 | 0 | 27 |
| 2019 | 9 | 33 | 2 | 40 |
| 2020 | 9 | 43 | 1 | 48 |
| 2021 | 13 | 48 | 0 | 47 |
| 2022 | 16 | 89 | 1 | 32 |
| 2023 | 3 | 55 | 6 | 77 |
| 2024 | 9 | 159 | 5 | 39 |
| 2025 | 11 | 153 | 47 | 27 |
| 2026 | 6 | 157 | 5 | — |
What is it indicated for?
The Sedecal Mobile Radiographic Systems with Digital Detector are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K043002 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043002: Sedecal Mobile X-Ray Units with Digital Detector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043002
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026